United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2008_register executive 2010-09-23 article Notices D09002ee1c808dbcf D09002ee1c808dc2d United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) are announcing a public technical meeting in preparation for a pilot program to enable pharmaceutical firms to evaluate proposed propriety names and submit the data generated from those evaluations to FDA for review. The purpose of the public technical meeting is to discuss a concept paper that describes the logistics of the pilot program, proposed recommendations for carrying out a proprietary name review, and the way FDA intends to review submissions made under the pilot program. FDA plans to formally issue the concept paper by the end of fiscal year (FY) 2008 and expects to begin enrollment in the pilot program in FY 2009. 73 FR 27001 https://www.govinfo.gov/app/details/FR-2008-05-12/E8-10513 E8-10513 fr12my08-46 4160-01-S Docket No. FDA-2008-N-0281 https://www.govinfo.gov/app/details/FR-2008-05-12/E8-10513 https://www.govinfo.gov/content/pkg/FR-2008-05-12/html/E8-10513.htm https://www.govinfo.gov/content/pkg/FR-2008-05-12/pdf/E8-10513.pdf 2 p. 27001 27002 73 FR 27001 Pilot Program to Evaluate Proposed Name Submissions; Concept Paper; Public Meeting; Federal Register Vol. 73, Issue NOTICE E8-10513 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2008-07-07 2008-05-23 Docket No. FDA-2008-N-0281 4160-01-S E8-10513 Notice of public meeting; request for comments.

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) are announcing a public technical meeting in preparation for a pilot program to enable pharmaceutical firms to evaluate proposed propriety names and submit the data generated from those evaluations to FDA for review. The purpose of the public technical meeting is to discuss a concept paper that describes the logistics of the pilot program, proposed recommendations for carrying out a proprietary name review, and the way FDA intends to review submissions made under the pilot program. FDA plans to formally issue the concept paper by the end of fiscal year (FY) 2008 and expects to begin enrollment in the pilot program in FY 2009.

The public meeting will be held on June 5 and 6, 2008, from 8:30 a.m. to 5 p.m. each day. Register to make a presentation at the meeting by May 23, 2008. See section III of this document for information on how to attend or present at the meeting. Submit any written or electronic comments regarding the concept paper and pilot program by July 7, 2008. Lana Pauls, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6196, Silver Spring, MD 20993, 301-796- 0518, FAX: 301-847-8753, e-mail: lana.pauls@fda.hhs.gov. Meetings: Pilot Program to Evaluate Proposed Name Submissions; Concept Paper, lana.pauls@fda.hhs.gov http://www.fda.gov/cder/meeting/drugNaming.htm http://www.fda.gov/ohrms/dockets/ac/acmenu.htm http://www.fda.gov/ohrms/dockets/ac/cder03.html#DrugSafetyRiskManagement http://www.regulations.gov Vol. 73, no. 92 Office of the Federal Register, National Archives and Records Administration 2008-05-12 continuing daily deposited born digital 528 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2008-05-12 P0b002ee1809bb1d3 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr12my08 https://www.govinfo.gov/app/details/FR-2008-05-12 https://www.govinfo.gov/content/pkg/FR-2008-05-12/pdf/FR-2008-05-12.pdf https://www.govinfo.gov/content/pkg/FR-2008-05-12/xml/FR-2008-05-12.xml fdlp 26941 27458 DGPO 2010-09-23 2024-06-05 FR-2008-05-12 machine generated eng FR FR-2008-05-12 73 92